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Clinical Systems Specialist
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Clinical Operations Specialist
2 weeks ago
The Senior Clinical Systems Analyst plays a vital role in ensuring the accuracy and completeness of clinical trial documents. This individual is responsible for creating, maintaining, and close-out of clinical trials using various eClinical systems.
Key responsibilities include performing TMF quality reviews, conducting periodic quality checks, drafting and reviewing quality plans, and communicating filing issues to the manager. Additionally, this position involves working with study owners on start-up, maintenance, and close-out activities, as well as managing user access to the eTMF system.
This role requires strong communication and interpersonal skills, with the ability to multitask and work under tight deadlines. The ideal candidate will have experience working with TMF documents, electronic documentation, and ICH/GCP guidelines.
">Required Skills and Qualifications:- Superior communication and problem-solving skills
- Strong experience with TMF documents, including filing and QC
- Proven experience in electronic documentation and eClinical systems
- Knowledge of ICH/GCP guidelines
- Proficiency in Microsoft Office and ability to build relationships with clients and coworkers
- Excellent leadership and organizational skills
This role offers the opportunity to work in a dynamic and growing industry, with opportunities for professional growth and development. The ideal candidate will be able to thrive in a fast-paced environment and contribute to the success of our organization.
Others:Line management or team lead experience is desirable, as is experience working with eTMF or other eClinical systems. If you are a motivated and organized individual with a passion for clinical trials, we encourage you to apply for this exciting opportunity.
